Dutasteride/tamsulosin CINFA 0.5 mg/0.4 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

dutasteride/tamsulosin cinfa 0.5 mg / 0.4 mg hard capsules EFG

dutasteride/tamsulosin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What dutasteride/tamsulosin cinfa is and what it is used for
2. What you need to know before taking dutasteride/tamsulosin cinfa
3. How to take dutasteride/tamsulosin cinfa
4. Possible side effects
5. How to store dutasteride/tamsulosin cinfa
6. Contents of the pack and other information

1. What dutasteride/tamsulosin cinfa is and what it is used for

dutasteride/tamsulosin cinfa is used in men to treat an enlarged prostate (benign prostatic hyperplasia) — a noncancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone.

Dutasteride/tamsulosin is a combination of two different medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of medicines known as 5-alpha reductase inhibitors, and tamsulosin belongs to a group of medicines known as alpha-blockers.

As the prostate enlarges, it can cause urinary problems such as difficulty in urine flow and a need to urinate more frequently. It may also cause the urine stream to become weaker and less forceful. If benign prostatic hyperplasia is left untreated, there is a risk that urine flow may become completely blocked (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be needed to reduce the size of the prostate or to remove it.

Dutasteride reduces the production of dihydrotestosterone, helping to shrink the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosin works by relaxing the muscles in the prostate, making urination easier and rapidly improving symptoms.

2. What you need to know before taking dutasteride/tamsulosin cinfa

Do not take dutasteride/tamsulosin cinfa:

• if you are a woman (because this medicine is for men only)
• if you are a child or adolescent under 18 years of age
• if you are allergic to dutasteride, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, soy, peanut, or to any of the other ingredients of this medicine (listed in section 6)
• this medicine contains lecithin which may contain soybean oil. It should not be used if you are allergic to peanut or soy
• if you have low blood pressure, which makes you feel dizzy, lightheaded, or causes fainting (orthostatic hypotension)
• if you have severe liver disease.

If you think you have any of these conditions, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take dutasteride/tamsulosin cinfa.

• In some clinical studies, there was a higher number of patients taking dutasteride and another medicine called an alpha blocker, such as tamsulosin, who experienced heart failure compared to patients taking only dutasteride or only an alpha blocker.

Heart failure means that your heart does not pump blood as it should.

• Make sure your doctor knows if you have liver problems. If you have any condition affecting your liver, you may need additional monitoring during treatment with dutasteride/tamsulosin.

• Make sure your doctor knows if you have severe kidney problems.

• Cataract surgery (cloudy lens). If you are scheduled for cataract surgery, your doctor may ask you to stop taking dutasteride/tamsulosin for a period before the operation. Before the surgery, inform your ophthalmologist that you are taking dutasteride/tamsulosin or tamsulosin (or have taken them previously). Your specialist will need to take appropriate precautions to avoid complications during surgery.

• Women, children, and adolescents must avoid contact with broken capsules of dutasteride/tamsulosin, as the active ingredient can be absorbed through the skin. If any contact with the skin occurs, the affected area should be washed immediately with soap and water.

• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or suspects she might be pregnant, you must avoid exposing her to your semen, as dutasteride may affect the normal development of a male baby. Dutasteride may reduce sperm count, sperm motility, and semen volume. This may reduce your fertility.

• Dutasteride/tamsulosin affects the serum PSA (prostate-specific antigen) test, which is sometimes used to detect prostate cancer. Your doctor may still use this test to screen for prostate cancer, but must be aware of this effect. If you have a blood test to measure your PSA, inform your doctor that you are taking dutasteride/tamsulosin.

Men being treated with dutasteride/tamsulosin should have regular PSA monitoring.

• In a clinical study in men at increased risk of prostate cancer, men taking dutasteride had a higher incidence of a more serious type of prostate cancer compared to those not taking dutasteride. The effect of dutasteride on this serious type of prostate cancer is not fully understood.

• Dutasteride/tamsulosin may cause breast enlargement and breast tenderness. If this causes discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes may be signs of a serious condition, such as breast cancer.

• Mood changes and depression. Depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with another medicine in the same therapeutic group (oral 5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor for medical advice as soon as possible.

Talk to your doctor or pharmacist if you have any questions about taking dutasteride/tamsulosin.

Other medicines and dutasteride/tamsulosin cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take dutasteride/tamsulosin with the following medicines:

• other alpha blockers (for enlarged prostate or high blood pressure).

Taking dutasteride/tamsulosin with the following medicines is not recommended:

• ketoconazole (used to treat fungal infections).

Certain medicines may interact with dutasteride/tamsulosin, increasing the risk of adverse effects. Some of these medicines are:

• PDE5 enzyme inhibitors (used to achieve or maintain an erection), such as vardenafil, sildenafil citrate, and tadalafil
• verapamil or diltiazem (for high blood pressure)
• ritonavir or indinavir (for HIV)
• itraconazole or ketoconazole (for fungal infections)
• nefazodone (an antidepressant)
• cimetidine (for stomach ulcers)
• warfarin (for blood clotting)
• erythromycin (an antibiotic used to treat infections)
• paroxetine (an antidepressant)
• terbinafine (used to treat fungal infections)
• diclofenac (used to treat pain and inflammation).

Inform your doctor if you are taking any of these medicines.

Taking dutasteride/tamsulosin cinfa with food and drink

You should take dutasteride/tamsulosin 30 minutes after the same meal each day.

Pregnancy, breastfeeding and fertility

Women must not take dutasteride/tamsulosin.

Pregnant women (or women who may be pregnant) must avoid contact with broken capsules. Dutasteride can be absorbed through the skin and may affect the normal development of a male baby. This risk is particularly important during the first 16 weeks of pregnancy.

Consult your doctor if a pregnant woman has been exposed to dutasteride/tamsulosin.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or suspects she might be pregnant, you must avoid exposing her to your semen.

Dutasteride/tamsulosin has been shown to reduce sperm count, sperm motility, and semen volume. This may reduce your fertility.

Driving and using machines

Some people may experience dizziness during treatment with dutasteride/tamsulosin, which could affect their ability to drive or operate machinery safely.

Do not drive or operate machinery if you are affected in this way.

dutasteride/tamsulosin cinfa contains sunset yellow FCF (E-110).

This medicine may cause allergic reactions as it contains sunset yellow FCF (E-110). It may cause asthma, particularly in patients allergic to acetylsalicylic acid.

dutasteride/tamsulosin cinfa contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially "sodium-free".

3. How to take dutasteride/tamsulosin cinfa

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you do not take dutasteride/tamsulosin regularly, your PSA levels monitoring may be affected. If in doubt, consult your doctor or pharmacist again.

What dose should you take

The recommended dose is one capsule once daily, taken 30 minutes after the same meal each day.

How to take it

The capsules must be swallowed whole with water. Do not chew or open the capsules. Contact with the capsule contents may irritate your mouth or throat.

If you take more dutasteride/tamsulosin cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take dutasteride/tamsulosin cinfa

Do not take a double dose to make up for missed doses. Take the next dose at the usual time.

If you stop taking dutasteride/tamsulosin cinfa

Do not stop treatment with dutasteride/tamsulosin without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Allergic reaction

Symptoms of an allergic reaction may include:

• rash (which may be itchy)
• hives (like urticaria)
• swelling of the eyelids, face, lips, arms, or legs.

Contact your doctor immediately if you experience any of these symptoms and stop taking dutasteride/tamsulosin.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosin may cause dizziness, lightheadedness, and in rare cases, fainting. You should be cautious when standing up quickly after sitting or lying down, especially if you need to get up during the night, until you know how this medicine affects you. If you feel dizzy or faint during treatment, sit or lie down until these symptoms have passed.

Serious skin reactions

Signs of serious skin reactions may include:

• widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

Contact your doctor immediately if you have these symptoms and stop using dutasteride/tamsulosin.

Common adverse effects

These may affect up to 1 in 10 patients taking dutasteride/tamsulosin:

• impotence (inability to achieve or maintain an erection)*

• decreased sexual desire (libido)*

• difficulty in ejaculation, with a reduction in the amount of semen released during sexual intercourse*

• increase in breast size and tenderness on palpation (gynecomastia)

• dizziness.

• In a small number of people, one or more of these adverse events may continue after stopping dutasteride/tamsulosin.

Uncommon adverse effects

These may affect up to 1 in 100 patients:

• heart failure (the heart becomes less efficient at pumping blood around the body. This could cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs)
• reduction in blood pressure upon standing
• faster than normal heartbeat (palpitations)
• constipation, diarrhoea, vomiting, feeling unwell (nausea)
• weakness or loss of strength
• headache
• itching, stuffiness, or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually of the body) or hair growth.

Rare adverse effects

These may affect up to 1 in 1,000 patients:

• swelling of the eyelids, face, lips, arms, or legs (angioedema)
• collapse.

Very rare adverse effects

These may affect up to 1 in 10,000 patients:

• prolonged and painful erection of the penis (priapism)
• serious skin reactions (Stevens-Johnson syndrome).

Other adverse effects

Other adverse effects have been reported in a small number of patients, but their frequency is unknown (frequency cannot be estimated from the available data):

• abnormal or rapid heartbeat (arrhythmia or tachycardia or atrial fibrillation)
• difficulty breathing (dyspnea)
• depression
• pain and swelling in the testicles
• nosebleed
• severe skin rash
• changes in vision (blurred vision or visual disturbances)
• dry mouth.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of dutasteride/tamsulosin cinfa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging or bottle after EXP. The expiry date refers to the last day of the month indicated.

For HPDE bottles, do not use for more than 6 weeks for the 30-capsule pack and more than 18 weeks for the 90-capsule pack, after first opening.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of dutasteride/tamsulosin cinfa

• The active substances are dutasteride and tamsulosin hydrochloride. Each hard capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride (equivalent to 0.367 mg of tamsulosin).

• The other components (excipients) are:

• hard capsule shell: hypromellose, carrageenan (E-407), potassium chloride, titanium dioxide (E-171), iron oxide red (E-172), and orange-yellow S (E-110).

• soft capsule contents: glycerol monocaprylocaprate, butylhydroxytoluene (E-321).

soft capsule shell: gelatin, glycerol, titanium dioxide (E-171), iron oxide yellow (E-172), medium-chain triglycerides, lecithin (may contain soybean oil) (E-322).

tamsulosin pellets: microcrystalline cellulose, methyl acrylate-acrylic acid copolymer and ethyl acrylate copolymer (1:1) dispersion 30%, methacrylic acid-ethyl acrylate copolymer (1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E-171).

Appearance of the product and contents of the pack

The medicine is presented as hard, oblong capsules with a brown body and an orange cap.

Each hard capsule contains modified-release pellets of tamsulosin hydrochloride and a soft gelatin capsule containing dutasteride.

It is available in high-density polyethylene (HDPE) bottles and aluminum-aluminum blisters containing 7, 30, and 90 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

SAG MANUFACTURING, S.L.U.

Ctra. N-I, Km 36

28750 San Agustín de Guadalix, Madrid (Spain)

or

Galenicum Health S.L.U.

Calle Sant Gabriel, 50, Esplugues de Llobregat, 08950, Barcelona (Spain)

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Dutasteride/Tamsulosin Cinfa 0.5 mg/0.4 mg hard capsules EFG - Spain

Date of the most recent review of this leaflet: September 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/84641/P_84641.html

QR code to: https://cima.aemps.es/cima/dochtml/p/84641/P_84641.html